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IRCT20180623040206N1 IRCT 2018-07-17 Research and Technology Deputy of Guilan University of Medical Sciences. "Assessing the effect of applying local cold and hot pack on the bruising extent of Enoxaparin sodium injection site in patients admitted " Assessing the effect of applying local cold and hot pack on the bruising extent of Enoxaparin sodium injection site in patients admitted 2018-07-10 anticipated 74 Complete https://irct.ir/trial/32108 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The samples size is 74. At first, the samples are selected by convenience sampling method and based on the inclusion criteria. Then, 37 subjects are allocated in the intervention group 1 (Local cold on the right side of the abdomen) and 37 in the intervention group 2 (Local cold- heat on the right side of the abdomen) based on the randomized blocking on a computer and obtaining a precise list in four block, Blinding description: Data on bruising is gathering through observing injection site for bruising and measuring its breadth by using a transparent millimeter ruler by afellow trained researcher who does not know any information about injection methods. N/A Diseases of skin and subcutaneouse tissue. Intervention 1: Intervention group1: Samples(n=37) will receive per-filled syringe of enoxaparin sodium 6000 IU (prepared by Alborzdarou company), subcutaneously after administration on the right of the abdomen,applying a cold pack at a place of injection for 20 minutes with a temperature of 15 to 18 ° C. . The injection area will be identifying circled about 2/5 cm diameter by a waterproof pen, and then providing the education to patient about non-manipulation, including the lack of massage, scratching or touching the injection site. I n general, the investigator inject in two times in each groups. The first injection on the right side of the abdomen is considered as an intervention and the second injection, which is performed 24 hours after the first injection on the left side of the abdomen, is considered as a control. There will be no intervention on the left side of the abdomen ( as control). Data on bruising is gathering through observing injection site for bruising and measuring its breadth by using a transparent millimeter ruler by a fellow trained researcher who does not know any information about injection methods. The bruising extent is recorded in up to 3 days at 24, 48, 72 hours after injection (right and left side of the abdomen) in each groups and recorded in the data sheet. Intervention 2: Intervention group2: Samples(n=37) will receive per-filled syringe of enoxaparin sodium 6000 IU (prepared by Alborzdarou company), subcutaneously after administration on the right of the abdomen,applying the cold pack for 20 minutes, 24 hours later, the warm pack with a temperature 40-43 ° C for 20 minutes is applied . The injection area will be identifying circled about 2/5 cm diameter by a waterproof pen, and then providing the education to patient about non-manipulation, including the lack of massage, scratching or touching the injection site. I n general, the investigator inject in two times in each groups. The first injection on the right side of the abdomen is considered as an intervention and the second injection, which is performed 24 hours after the first injection on the left side of the abdomen, is considered as a control. There will be no intervention on the left side of the abdomen ( as control). Data on bruising is gathering through observing injection site for bruising and measuring its breadth by using a transparent millimeter ruler by a fellow trained researcher who does not know any information about injection methods. The bruising extent is recorded in up to 3 days at 24, 48, 72 hours after injection (right and left side of the abdomen) in each groups and recorded in the data sheet. Yes - There is a plan to make this available What will be shared: Total of data is Shareable after unidentifiable the people. When: Start the access period 6 months after printing the results To whom: Only for researchers working in academic and scientific institutions Conditions: Meta analysis Where to obtain: Ataollah Asadi Louyeh Guilan University of Medical Sciences. Shahid Beheshti Nursing and Midwifery School of Rasht How to obtain: contact by email Comments:
public Ataollah asadi louyeh
Daneshjoo street, Western Beheshti Boulvard, Beheshti nursing and midwifery college
Rasht Iran (Islamic Republic of) 39841-41469 +98 13 3355 5056 aa.louyeh@gums.ac.ir Guilan university of medical sciences,Beheshti nursing and midwifery college scientific Ataollah asadi louyeh
Beheshti nursing and midwifery college, Daneshjoo street, Western Beheshti Boulvard
Rasht Iran (Islamic Republic of) 39841-41469 +98 13 3355 5056 aa.louyeh@gums.ac.ir Guilan university of medical sciences,Beheshti nursing and midwifery college Iran (Islamic Republic of) requiring hospital admission for at least 72 hours after receiving the second injection in the left abdomen treatment with Enoxaparin sodium with a dose of 6000 units having the results of the latest coagulation tests include INR, PTT, PT in the range of therapy (up to 1.5-2.5 as normal), normal amounts of platelets and hematocrit adequate renal function (creatinine 1.5-0.5 mg / dL) lack of extensive skin lesions on the abdomen such as extensive scarring due to surgery or burn lack of conditions preventing the correct implementation of the Enoxaparin injection method such as sever Ascites abdominal bruises from the previous injection satisfaction to participate in the research by signing a written consent no limit no limit Both event of any change in the clinical condition is required changing in the amount or discontinuation of the drug performing subcutaneous injections Enoxaparin sodium on the right side of the abdomen by personnel unwillingness to continue cooperation XII L00-L99 Prevention Prevention Intervention group1: Samples(n=37) will receive per-filled syringe of enoxaparin sodium 6000 IU (prepared by Alborzdarou company), subcutaneously after administration on the right of the abdomen,applying a cold pack at a place of injection for 20 minutes with a temperature of 15 to 18 ° C. . The injection area will be identifying circled about 2/5 cm diameter by a waterproof pen, and then providing the education to patient about non-manipulation, including the lack of massage, scratching or touching the injection site. I n general, the investigator inject in two times in each groups. The first injection on the right side of the abdomen is considered as an intervention and the second injection, which is performed 24 hours after the first injection on the left side of the abdomen, is considered as a control. There will be no intervention on the left side of the abdomen ( as control). Data on bruising is gathering through observing injection site for bruising and measuring its breadth by using a transparent millimeter ruler by a fellow trained researcher who does not know any information about injection methods. The bruising extent is recorded in up to 3 days at 24, 48, 72 hours after injection (right and left side of the abdomen) in each groups and recorded in the data sheet. Intervention group2: Samples(n=37) will receive per-filled syringe of enoxaparin sodium 6000 IU (prepared by Alborzdarou company), subcutaneously after administration on the right of the abdomen,applying the cold pack for 20 minutes, 24 hours later, the warm pack with a temperature 40-43 ° C for 20 minutes is applied . The injection area will be identifying circled about 2/5 cm diameter by a waterproof pen, and then providing the education to patient about non-manipulation, including the lack of massage, scratching or touching the injection site. I n general, the investigator inject in two times in each groups. The first injection on the right side of the abdomen is considered as an intervention and the second injection, which is performed 24 hours after the first injection on the left side of the abdomen, is considered as a control. There will be no intervention on the left side of the abdomen ( as control). Data on bruising is gathering through observing injection site for bruising and measuring its breadth by using a transparent millimeter ruler by a fellow trained researcher who does not know any information about injection methods. The bruising extent is recorded in up to 3 days at 24, 48, 72 hours after injection (right and left side of the abdomen) in each groups and recorded in the data sheet. The extent of bruising in area of Enoxaparin sodium in Milimeter. Timepoint: 24,48 and 72 hours after intervention. Method of measurement: Recording the bruising extent based on multiplication of the largest diameter in the smallest diameter (by flexible ruler in millimeter) in prepared form. The incidence of bruising in site of Enoxaparin sodium injection:discoloration in skin to violet color at least 2 mm. Timepoint: 24,48 and 72 hours after intervention. Method of measurement: Recording the observed bruising in prepared form by flexible ruler in millimeter)to measure skin discoloration. Research and Technology Deputy of Guilan University of Medical Sciences. Approved 2018-06-11 Ethics committee of Guilan University of Medical Sciences Eastern Shahid Beheshti Boulvard, Vice Chancellor for research of Guilan University of Medical Sciences Rasht Guilan Iran (Islamic Republic of)